Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during therapeutic laser proc...
Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.
A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy options to be conside...
FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibito...
FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.
Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples...
FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).
Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its Health Analytics pra...
